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PubMed2005

United States Pharmacopeia activities in the area of vaccines, virology and immunology.

The United States Pharmacopeia (USP) develops public standards for medical products that are enforceable by FDA. USP general information chapters have been providing industrial and academic researchers alike with crucial guidance especially in areas where there is absence of regulatory guidance. In an effort to meet the challenge of rapid advances in vaccine research and manufacturing, the Council of Experts Committee for Vaccines, Virology, and Immunology of the US Pharmacopeia has recently initiated two new general chapters to provide advice for researchers and manufacturers in the vaccine and virology fields and beyond. Chapter 1235 Vaccines and Vaccine Test Methods will focus on manufacturing and analytical requirements for the different types of vaccines currently in manufacture and development. Chapter 1237 Virology Test Methods will discuss modern diagnostic virology techniques and a variety of tests as applicable to vaccine and biologics manufacturing.

Allergy and Immunology↗
PubMed2001

Determination of iodide with 1,3-dibromo-5,5-dimethylhydantoin (DBH) in comparison with the ICl-method. Analytical methods of pharmacopeias with DBH in respect to environmental and economical concern. Part 3.

USP 1995 (The United States Pharmacopeia, 23rd Edit., (1995), potassium iodide p. 1265, sodium iodide p. 1424), PH. EUR. 1997 (European Pharmacopoeia, third ed., Council of Europe, Strasbourg, (1997), potassium iodide p. 1367, sodium iodide p. 1493) and JAP 1996 (The Japanes Pharmacopoeia, 13th ed. (1996), potassium iodide p. 578, sodium iodide p. 630) determine iodide with the ICl-method (J. Am. Chem. Soc. 25 (1903) 756-761; Z. Anorg. Chem. 36 (1903) 76-83; Fresenius Z. Anal. Chem. 106 (1936) 12-23; Arzneibuch-Kommentar, Wissenschaftliche Erläuterungen zum Europäischen Arzneibuch, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, Govi-Verlag - Pharmazeutischer Verlag GmbH, Eschborn, 12th suppl. (1999), K10 p. 2), using chloroform, which is toxic and hazardous to environment. Without the application of chlorinated hydrocarbons USP 2000 (The United State Pharmacopeia, 24th ed. (2000), potassium iodide p. 1368, sodium iodide p. 1535) and Brit 1999 (British Pharmacopoeia London, (1999), Appendix VIII C, p. A162) titrate iodide with the redox indicator amaranth. A titration with potentiometric indication giving two end-points at the step of I(2) and [ICl(2)](-) is described. Due to the high concentration of hydrochloric acid required for the ICl-method, the determination with DBH (1,3-dibromo-5,5-dimethylhydantoin; 1,3-dibromo-5,5-dimethyl-2,4-imidazolidinedione) can be recommended and is performed easily. Similarly, the iodide content of gallamine triethiodide may be analyzed with DBH by application of a visual two-phase titration in water and ethyl acetate or with potentiometric indication in a mixture of 2-propanol and water. During the removal of the excess of DBH 4-bromo-triethylgallamine (2,2',2"-[1-bromo-benzene-2,3,4-triyltris(oxy)]N,N,N-triethylethanium) is formed.

Hydantoins↗
PubMed2002

Determination of selenium sulfide using 1,3-dibromo-5,5-dimethylhydantoin (DBH). Analytical methods of pharmacopeias with DBH in respect to environmental and economical concern Part 11.

USP 2000 (The United States Pharmacopeia, Rockville, MD, 24th ed., 2000, pp. 1514-1515) and PH. EUR. 1997 (European Pharmacopoeia, 3rd ed., Council of Europe, Strasbourg, 1997, p. 1459) dissolve selenium sulfide by boiling with fuming nitric acid for about 1 h. After cooling to room temperature and dilution with water nitrous acid and nitrogen oxides are removed with urea also by boiling before the iodometric titration is performed. This method can be importantly simplified and improved, when using 1,3-dibromo-5,5-dimethylhydantoin (DBH) in glacial acetic acid in presence of solid potassium bromide. Selenium sulfide is dissolved during 5-10 min at room temperature. The excess of DBH and bromine can be removed with 5-sulfosalicylic acid also without boiling. The point of the indicator change for the iodometric titration is improved in comparison to the method of the pharmacopeias, because the colloidal solution of selenium mostly coagulates. Also the sulfur content of selenium sulfide can be determined with DBH.

Bromides↗
PubMedDate not supplied

Comparison of temperature rise interpretations between European and United States Pharmacopeias' pyrogen tests.

The European Pharmacopeia (EP) and the United States Pharmacopeia (USP) pyrogen test for parenterals involve the measurement of the temperature rise in rabbits following the intravenous injection of the test solution. Between the two methods, the conditions for the result "pyrogen free" or "pyrogen", as well as the number of rabbits tested, differ substantially. Therefore, both methods were compared with respect to the differences in temperature rise interpretations with special attention to the selectivity of the tests. To exclusively study the temperature rise interpretations, the temperature measurements were simulated with models. With an increasing mean temperature rise, an intermediate range exists where the probability of "pyrogen free" and of "pyrogen" cannot be ignored. A single pyrogen test still gives an unambiguous result, but in this range, the probability is rather high that additional tests will not reproduce the same result. This range is approximately 0.3 degrees C wide for the USP test and 0.2 degrees C wide for the EP test. Simulating the temperature rise with a normally distributed model, the intermediate range is narrower for the interpretation according to the EP than the USP. For a USP test, the probability of the test result "pyrogen free" decreases as lower mean temperature rises. However, the two methods are similar in the high probability range for the presence of pyrogens. At the edge of the intermediate range, a slight mean temperature rise of 0.05 degrees C significantly changes the probability of a pyrogen result. Within a rather wide mean temperature rise range (approximately 0.15 degrees C wide), a product will reliably fulfil the EP requirements but not the USP requirements. These main statements are rather robust and do not depend significantly on the model used. Different temperature rise distributions only result in negligible variations in the interpretation of the tests. Information more detailed than mean temperature rise and standard deviation of the temperature rises is not absolutely necessary. For product quality, it is much more useful to review and interpret all individual temperature rises measured than to interpret the results of the pyrogen test only [corrected].

Animals↗
PubMed2006

Narrative review: the U.S. Pharmacopeia and model guidelines for Medicare Part D formularies.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 includes a provision directing the Secretary of the U.S. Department of Health and Human Services to request that the U.S. Pharmacopeia (USP) develop a list of categories and classes (the USP Model Guidelines) that can be used by prescription drug plans in developing their formularies for the Part D prescription drug benefit. The Centers for Medicare & Medicaid Services (CMS) used the Model Guidelines and USP's related listing, termed the Formulary Key Drug Types, to evaluate prescription drug plan formularies submitted by prescription drug plan sponsors intending to provide the new Part D benefit. This article recounts how USP's all-volunteer Model Guidelines Expert Committee developed the USP Model Guidelines and Formulary Key Drug Types, working under a cooperative agreement with CMS in response to the Secretary's request. The Model Guidelines and Formulary Key Drug Types are updated annually to reflect advances in evidence-based medicine, thereby offering timely guidance to CMS and to prescription drug plans based on USP's demonstrated expertise in setting standards.

Drug Prescriptions↗
PubMed2003

Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization.

One of the most critical factors in developing pharmaceutical drug substances and drug products today is ensuring that the HPLC analytical test methods that are used to analyze the products generate meaningful data. The US Food and Drug Administration (FDA) and United States Pharmacopeia (USP) have each recognized the importance of this to the drug development process and have separately increased validation requirements in recent years. A third source, the International Conference on Harmonization (ICH), has added requirements that, when combined with the previous two sources, have led to three different sets of validation requirements leaving the industry in a state of confusion. This paper is written to clear up the confusion over the validation requirements that are presented by each of these three sources.

Chromatography, High Pressure Liquid↗